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Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin

a glycopeptide antibiotic and composition technology, applied in the direction of powder delivery, macromolecular non-active ingredients, dispersion delivery, etc., can solve the problems of excessive tissue accumulation, undesirable properties of glycopeptide antibiotics, sterically impractical and/or synthetically non-feasible,

Inactive Publication Date: 2002-06-20
CUMBERLAND PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] By reducing the undesirable effects of the glycopeptide (e.g. nephrotoxicity), administration of the glycopeptide in combination with a cyclodextrin increases the therapeutic window for the glycopeptide, and allows a greater amount to be administered.

Problems solved by technology

However, when administered to a mammal, some glycopeptide antibiotics exhibit undesirable properties, such as excessive tissue accumulation, nephrotoxicity, histamine release (Red Man Syndrome) and vascular irritation.
As to any of the above groups which contain one or more substituents, it is understood, of course, that such groups do not contain any substitution or substitution patterns which are sterically impractical and / or synthetically non-feasible.

Method used

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  • Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin
  • Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin
  • Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin

Examples

Experimental program
Comparison scheme
Effect test

formulation example b

[0190] This example illustrates the preparation of a representative pharmaceutical composition containing a compound of this invention.

[0191] A frozen solution suitable for injection is prepared having the following composition:

2 Frozen Solution Active Compound 250 mg to 1000 mg Hydroxypropyl-.beta.-cyclodextrin 250 mg to 10 g Excipients - e.g., dextrose 0-50 g Water for Injection 10-100 mL The weight ratio of hydroxypropyl-.beta.-cyclo-dextrin to the active compound will typically be from about 1:1 to about 10:1.

[0192] Representative Procedure: Hydroxypropyl-p-cyclodextrin and excipients, if any, are dissolved in about 80% of the water for injection and the active compound is added and dissolved. The pH is adjusted with 1 M sodium hydroxide to 4.7.+-.0.3 and the volume is then adjusted to 95% of the final volume with water for injection. The pH is checked and adjusted, if necessary, and the volume is adjusted to the final volume with water for injection. The formulation is then ste...

formulation example c

[0193] This example illustrates the preparation of a representative pharmaceutical composition containing a compound of this invention.

[0194] A lyophilized powder useful for preparing an injectable solution is prepared having the following composition:

3 Lyophilized Powder Active Compound 250 mg to 1000 mg Hydroxypropyl-.beta.-cyclodextrin 250 mg to 10 g Excipients - e.g., mannitol, 0-50 g sucrose and / or lactose Buffer agent - e.g., citrate 0-500 mg The weight ratio of hydroxypropyl-.beta.-cyclodextrin to the active compound will typically be from about 1:1 to about 10:1.

[0195] Representative Procedure: Hydroxypropyl-.beta.-cyclodextrin and excipients and / or buffering agents, if any, are dissolved in about 60% of the water for injection. The active compound is added and dissolved and the pH is adjusted with 1 M sodium hydroxide to 4.0-5.0 and the volume is adjusted to 95% of the final volume with water for injection. The pH is checked and adjusted, if necessary, and the volume is adj...

formulation example d

[0197] This example illustrates the preparation of a representative pharmaceutical composition containing a compound of this invention.

[0198] A sterile powder useful for preparing an injectable solution is prepared having the following composition:

4 Sterile Powder Active Compound 250 mg to 1000 mg Hydroxypropyl-.beta.-cyclodextrin 250 mg to 10 g.sup.1 Excipients optional The weight ratio of hydroxypropyl-.beta.-cyclodextrin to the active will typically be from about 1:1 to about 10:1.

[0199] Representative Procedure: Hydroxypropyl-.beta.-cyclodextrin and the active compound (and any excipients) are dispersed into an appropriate sterile container and the container is sealed (optionally under partial vacuum or dry nitrogen), labeled and stored at room temperature or under refrigeration.

[0200] Administration of representative formulations C and D to a Patient

[0201] The pharmaceutical formulations described in formulation examples H and I above can be administered intravenously to a pati...

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Abstract

Disclosed are pharmaceutical compositions containing a cyclodextrin and a therapeutically effective amount of a glycopeptide antibiotic or a salt thereof. Also disclosed are methods of treating a bacterial disease in a mammal by administering such pharmaceutical compositions.

Description

PRIORITY OF INVENTION[0001] This application claims priority to United States Provisional Application No. 60 / 201,178, filed 02 May 2000; and to United States Provisional Applications Nos. 60 / 213,415; 60 / 213,410; 60 / 213,417; 60 / 213,146; 60 / 213,428, all filed 22 Jun. 2000; and to United States Provisional Application No. 60 / 226,727, filed 18 Aug. 2000, which applications are incorporated herein by reference in their entirety.[0002] 1. Field of the Invention[0003] This invention is directed to novel pharmaceutical compositions comprising a cyclodextrin and a therapeutically effective amount of a glycopeptide antibiotic. This invention is also directed to methods for treating a bacterial disease in a mammal using such pharmaceutical compositions.[0004] 2. State of the Art[0005] Glycopeptide antibiotics and lipidated derivatives thereof are well-known in the art (see Glycopeptide Antibiotics, edited by R. Nagaraj an, Marcel Dekker, Inc. New York (1994)). These glycopeptide compounds are ...

Claims

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Application Information

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IPC IPC(8): A61K38/00A61K9/00A61K9/02A61K9/14A61K9/19A61K9/20A61K9/48A61K47/06A61K47/12A61K47/26A61K47/40A61K47/48A61K51/08A61P31/04C07F9/38C07K1/113C07K9/00
CPCA61K9/0014C07K9/008A61K9/0095A61K9/02A61K9/19A61K9/2018A61K9/4858A61K31/724A61K38/14A61K47/06A61K47/12A61K47/26A61K47/40A61K47/48969B82Y5/00A61K9/0019A61K47/6951A61P31/00A61P31/04
Inventor JUDICE, J. KEVINSHAW, JENG-PYNGMU, YONGQICONNER, MICHAEL W.
Owner CUMBERLAND PHARM INC
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